Ostomy appliance

ABSTRACT

An ostomy appliance comprising a body side member comprising an adhesive wafer for securing the appliance to the user&#39;s skin, said wafer having a hole for receiving a stoma, wherein the body side member comprises first substantially annular coupling means for releasable attachment of a separately exchangeable receiving bag to the body side ostomy member for receiving secretions from the stoma, said receiving bag comprising matching substantially annular coupling means, wherein the body side member comprises a separate sealing member for sealing against the stoma, wherein the separate sealing member is in the form of a disc having a centre hole for accommodating the stoma and wherein at least the skin-contacting surface of the disc comprises a mass of a adhesive, wherein the disc facing the skin of the user has a maximum outer diameter corresponding to the inner diameter of the first annular coupling means and wherein the centre hole of the disc has a diameter smaller than the diameter of the stoma-receiving hole of the body side member ensuring that the disc covers all of the surface of the adhesive wafer facing away from the user located between the first annular coupling means and the stoma, said disc being made from a material that may be detached, rinsed and reapplied offers a body side member comprising a sealing member which may be removed, washed and reused, which has a service time at least as long as the body side member, and which reduces the frequency of stressing the skin around the stoma due to exchange of the body side member by protecting the surface of the adhesive wafer from soiling by and attack from the aggressive visceral contents and facilitates the cleaning of the body side member.

BACKGROUND OF THE INVENTION

[0001] 1. Field of the Invention

[0002] The present invention relates to an ostomy appliance comprising abody side member comprising an adhesive wafer for securing the applianceto a user's skin, said wafer having a hole for receiving a stoma, and aseparately exchangeable receiving bag secured to the body side ostomymember for receiving fluids or excretions emerging from an abdominalstoma and a sealing member for sealing between a stoma and an ostomybody side member.

[0003] In connection with surgery for a number of diseases in thegastrointestinal or urinary tract a consequence is, in many cases, thatthe colon, the ileum or the ureter has been exposed surgically and thepatient is left with an abdominal stoma, or, in nephrostomy orureterostomy, the ureter or a catheter is exposed in the back or thechest region or abdominal region, and the effluents or waste products ofthe body, which are conveyed through these organs, are dischargedthrough the artificial orifice or opening and are collected in acollection bag, which is usually adhered to the skin by means of anadhesive wafer or plate having an inlet opening for accommodating thestoma/ureter/catheter. Also in connection with a fistula, the patientwill have to rely on an appliance to collect the bodily materialemerging from such opening.

[0004] Ostomy appliances are well known. Such appliances may betwo-piece or one-piece appliances. In both types of appliances, anadhesive barrier member (or base plate) is attached to the wearer'sabdomen/back/chest. In case of a one-piece appliance, a receiving memberor bag is attached to the base plate. In case of a two-piece appliance,the adhesive barrier member forms part of a body side member and areceiving member or bag is attached releasably to the body side ostomymember for receiving exudates from the stoma.

[0005] When using one-piece appliances, the whole appliance, includingthe adhesive skin barrier securing the appliance to the skin is normallyremoved and replaced by a fresh appliance. When using two-pieceappliances, the body side ostomy member is left in place up to severaldays, and only the receiving member or bag attached to the body sidemember is replaced. The attachment means for attaching an ostomyreceiving bag may e.g. be a system se comprising matching coupling ringsor matching flanges and adhesive surfaces engaging with and sealingagainst a flange area of the body side member.

[0006] 2. Description of the Related Art

[0007] Published International Patent Application No. WO 98/17212discloses an ostomy appliance comprising a body side member comprisingan adhesive wafer or pad for securing the appliance to the user's skin,said wafer or pad having a hole for receiving a stoma, and an optionallyseparately exchangeable receiving member or bag secured to the body sideostomy member for receiving secretions from the ostomy said ostomyappliance further comprising a separate sealing member disposed in thehole of the wafer or pad surrounding the stoma, said sealing memberbeing of a hypo-allergenic adhesive and being in the form of a mouldablemass or a ring.

[0008] Published International Patent Application No. WO 00/49981discloses an ostomy appliance comprising a body side member, anoptionally separately exchangeable receiving member or bag secured tothe body side member, said body side member comprising a ring-shapedbody having an adhesive wafer having a hole for accommodating a stomaand further a separate sealing member is in the form of a disc which,when in use, is placed in the hole for sealing against the stoma,wherein the disc has an outer diameter smaller than the diameter of thehole of the wafer or pad of the ostomy body side member and a flangemember stretching from its outer rim, and wherein the flange has outerdimensions greater than the diameter of the hole of the body side memberfor coupling to the body side member.

[0009] Published International Patent Application No. WO 98/53771 alsodiscloses an ostomy appliance comprising a body side member comprisingan adhesive wafer or pad for securing the appliance to the user's skin,said wafer or pad having a hole for receiving a stoma, and an optionallyseparately exchangeable receiving member or bag secured to the body sideostomy member for receiving secretions from the ostomy said ostomyappliance further comprising a sealing member disposed in the hole ofthe wafer or pad surrounding the stoma wherein the sealing memberdisposed in the hole of the wafer or pad surrounding the stoma, saidsealing member having a hole for accommodating the stoma and saidsealing member having balanced plastic and elastic properties allowingan adaptation of the hole of the ostomy appliance to a stoma by atemporary enlarging the hole by everting or rolling up the inner rim ofthe hole for accommodating the stoma.

[0010] Published International Patent Application No. WO 98/53772discloses an ostomy appliance comprising a body side, member comprisingan adhesive wafer or pad for securing the appliance to the user's skin,said wafer or pad having a hole for receiving a stoma, and an separatelyexchangeable receiving member or bag secured to the body side ostomymember for receiving secretions from the ostomy said ostomy appliancefurther comprising a separate sealing member disposed in the hole of thewafer or pad surrounding the stoma wherein the separately exchangeablereceiving member or bag is secured releasably to the body side ostomymember by a mechanical fastening means.

[0011] Although the above references disclose the use of a separatesealing member there is still need of a separate sealing member that maybe used together with conventional two-piece ostomy appliances in orderto allow an extension of the service time of the body side member foruse with an increased number of receiving bags and thus reduce thefrequency of stressing the skin around the stoma due to exchange of thebody side member by protecting the surface of the adhesive wafer fromsoiling by and attack from the aggressive visceral contents andfacilitating the cleaning of the body side member. Furthermore, there isa need of an improved protecting sealing member improving the safety andquality of life of ostomates having an active social life without havingto carry both fresh collecting bags and fresh sealing members whilebeing out of the daily whereabouts.

SUMMARY OF THE INVENTION

[0012] The present invention relates to an ostomy appliance comprising abody side member comprising an adhesive wafer for securing the applianceto the user's skin, said wafer having a hole for receiving a stoma,wherein the body side member comprises first substantially annularcoupling means for releasable attachment of a separately exchangeablereceiving bag to the body side ostomy member for receiving secretionsfrom the stoma, said receiving bag comprising matching secondsubstantially annular coupling means, wherein the body side membercomprises a separate sealing member for sealing against the stoma,wherein the separate sealing member is in the form of a disc having acentre hole for accommodating the stoma and wherein at least the surfaceof the disc facing the skin of the user comprises a mass of askin-friendly adhesive.

[0013] Furthermore, the invention relates to a sealing member forsealing between a stoma and an ostomy body side member comprising anadhesive wafer for securing the appliance to the user's skin, said waferhaving a hole for receiving a stoma, wherein the body side membercomprises first substantially annular coupling means for releasableattachment of a separately exchangeable receiving bag to the body sideostomy member for receiving secretions from the stoma which sealingmember is in the form of a disc having a centre hole for accommodatingthe stoma and wherein at least the surface of the disc facing the skinof the user comprises a mass of a skin-friendly adhesive.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention is disclosed more in detail with reference to thedrawings in which the FIGURE shows a sectional view of an embodiment ofthe invention in which a sealing disc is placed within the limits of acoupling ring of an ostomy body side member being situated on the user.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0015] The invention relates to an ostomy appliance comprising a bodyside member comprising an adhesive wafer for securing the appliance tothe user's skin, said wafer having a hole for receiving a stoma, whereinthe body side member comprises first substantially annular couplingmeans for releasable attachment of a separately exchangeable receivingbag to the body side ostomy member for receiving secretions from thestoma, said receiving bag comprising matching second substantiallyannular coupling means, wherein the body side member comprises aseparate sealing member for sealing against the stoma, wherein theseparate sealing member is in the form of a disc having a centre holefor accommodating the stoma and wherein at least the surface of the discfacing the skin of the user comprises a mass of a skin-friendlyadhesive, wherein the disc has a maximum outer diameter corresponding tothe inner diameter of the first annular coupling means and wherein thecentre hole of the disc has a diameter smaller than the diameter of thestoma-receiving hole of the body side member ensuring that the disccovers all of the surface of the adhesive wafer facing away from theuser located between the first annular coupling means and the stoma,said disc being made from a material that may be detached, rinsed andreapplied.

[0016] It has been found that an ostomy appliance of the inventionfulfils the above needs and also provides further advantages as appearsfrom the below. The sealing member of the invention protects the bodyside member against contact with and attack by the aggressive visceralcontents and has a service time at least corresponding to and evenexceeding the service time of the body side member. Thus, it betterprotects the body side member from soiling and also eases the cleaningthereof using water when substituting the receiving bag. This alsorenders it possible to extend the service time of the sealing member tocover at least the service time of the body side member and severalchanges of collecting bag. Thus, when changing bag while being out ofthe daily whereabouts, the ostomate may reuse the sealing member andthus does not have to carry both fresh collecting bags and fresh sealingmembers.

[0017] As the outer diameter of the disc corresponds to the innerdiameter of the coupling means, the adaptation of the hole of the bodyside member to the stoma less critical as the disc covers all of thesurface of the body side member inside the coupling means and thusprotects the surface of the body side member from contact with visceralcontents reducing the need of cleaning when substituting the collectionbag with a fresh. This also enables the option of using body sidemembers having a large hole generally and to avoid the individualadaptation of the size of the hole in most cases. Furthermore, only arelatively few number of sizes of sealing members of the invention,corresponding to the number of sizes of coupling rings, are needed,which sealing members furthermore only have to be adapted with respectto the size of the centre hole in order to provide a safe sealing whichsimplifies the use of the sealing members.

[0018] It is preferred that the diameter of the centre hole of thesealing member corresponds to the diameter of the stoma which ensures acomplete protection of the body side member as well as of the skinsurrounding the stoma.

[0019] In one embodiment of the invention the coupling means is in theform of matching flanges and adhesive surfaces.

[0020] In a preferred embodiment of the invention the annular couplingmeans is in the form of matching coupling rings.

[0021] In accordance with a further preferred embodiment of theinvention, the thickness of the sealing member is of the same size asthe distance between the surface of the adhesive wafer facing away fromthe user and the top of the coupling ring or the flange as the sealingmember then covers and protects the full surface of the first couplingmeans facing the stoma and thus reduces the risk of soiling of parts ofthe body side member and consequently also reduces the necessarycleaning.

[0022] It is preferred that the whole disc is made from an adhesivebeing resistant to attack from visceral contents as it is supposed to bein service for extended periods of time.

[0023] In order to facilitate cleaning of the body side member whensubstituting receiving bags it is preferred that the skin-friendlyadhesive is suitable for repeated adhering to and removal from the skin.Thus, the sealing member may be removed from the body side member andcleaned and repositioned and used for further protection of the bodyside member. It is especially preferred that the skin-friendly adhesiveis made from a permanently tacky silicone adhesive as such material maybe cleaning using water and does not bind materials or odour emergingfrom a stoma. Thus a clean environment is easy to maintain.

[0024] In accordance with a preferred embodiment the surface of the discfacing away from the user is covered with a non-tacky layer in order toreduce the risk of adherence of materials emerging from a stoma or theopposite bag wall if it is brought in contact with the disc by accident.

[0025] One practical solution is obtained when the surface facing awayfrom the user is covered with a non-tacky polymer film, e.g. a film of apolyolefin such as polyethylene or polypropylene or a silicone polymer.

[0026] The disc is preferably made form a silicone material as siliconematerials are generally skin-friendly and very stable when contacted byaggressive exudates from a stoma and furthermore, silicones may becleaned by rinsing with water without having to rely on the use ofdetergents which further facilitates repeated cleaning and use of asealing member. Furthermore, silicones are often transparent enabling aninspection of the area around the stoma without having to remove thesealing disc which reduces the stress of the skin connected with removaland replacing the sealing disc. Still further, when producing sealingmembers from silicones, it is not necessary to rely on protecting orcontainment sheet materials.

[0027] A preferred material for the non-tacky layer is a silicone rubberbeing relatively inert for aggressive fluids and being washable usingwater. Suitable materials are platinum catalysed vinyl endblockedpolydiorganosiloxanes of the kind described in U.S. Pat. No. 3,983,298,which have high tack, good adhesive strength. The properties and tack ofthese polysiloxanes may be adjusted according to wish by routineexperiments by the skilled in the art for preparation of more tackymaterials for adhering to the skin and less tacky or non-tacky layersfor the surface facing away from the user. A preferred material is vinylendblocked crosslinked polydimethylsiloxanes. Furthermore, it ispreferred that the surface of the disc facing away from the user ishydrophobic as this facilitates the cleansing thereof.

[0028] The sealing member used in accordance with the invention may beelastic enabling a temporary enlargement of the hole for receiving thestoma whereafter the disc reverts to substantially its original shape aslong as the elastic force is not so strong that there is a risk ofconstricting the stoma. Its is also considered an embodiment of theinvention that the sealing member is plastically mouldable allowing afinal adaptation of the shape thereof to fit more snugly to the stoma.

[0029] It is also contemplated that the sealing member used inaccordance with the invention is somewhat plastic allowing for a minordisplacement of material to allow a full engagement with the surface ofthe stoma.

[0030] It is preferred that the material is slightly conformable andadapts itself to the actual surface of the stoma. This active adaptationis more efficient when the sealing member is of a thicknesscorresponding to the height of a coupling ring.

[0031] The choice of materials having the above-referenced propertiesmay made by the skilled in the art based on routine experiments.

[0032] An ostomy body side member according to the invention may beproduced from standard materials normally used for preparation ofdisposable ostomy and wound and incontinence devices. Thus, the carriersheet may be any suitable thermoplastic material and the adhesive wafermay be made from a medical grade barrier adhesives known in the such asthe formulation being disclosed, for example in U.S. Pat. Nos.4,367,732, 5,051,259 or 5,714,225.

[0033] The coupling means-may be any system known per se for attachingreceiving bags to ostomy body side members and may suitably be matchingcoupling rings of the type disclosed in WO 93/18725 or WO 94/18919 ormatching flanges for adhesive connection of the type disclosed in U.S.Pat. No. 5,800,415.

[0034] In a further aspect the invention relates to a sealing member forsealing between a stoma and an ostomy body side member comprising anadhesive wafer for securing the appliance to the user's skin, said waferhaving a hole for receiving a stoma, wherein the body side membercomprises first substantially annular coupling means for releasableattachment of a separately exchangeable receiving bag to the body sideostomy member for receiving secretions from the stoma which sealingmember is in the form of a disc having a hole for accommodating thestoma and wherein at least the surface of the disc facing the skin ofthe user comprises a mass of a skin-friendly adhesive wherein the dischas a maximum outer diameter corresponding to the inner diameter of thefirst annular coupling means and wherein the centre hole of the disc hasa diameter smaller than the diameter of the stoma-receiving hole of thebody side member with which it is intended to be used.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] The invention is now explained more in detail with reference tothe drawings showing preferred embodiments of the invention.

[0036] Reference is made to the FIGURE of the drawings showing asectional view of an embodiment of an ostomy body side member of theinvention in which a sealing disc 1 is placed within the limits of acoupling ring 2 of the body side member 3 being situated on the user. Asappears, the disc has an opening 4 for receiving a stoma 5 and fills outthe space between the stoma 5 the coupling, ring 2 for releasableattachment of a receiving bag. Thus, the disc has an outer diametercorresponding to the inner diameter of the coupling ring so that thedisc and the coupling ring are in sealing contacting in the interface 6and the diameter of the centre hole or opening 4 is smaller than thediameter of the stoma-receiving hole 7 of the body side member.

[0037] As also appears, the sealing disc 1 protects all of the surfaceof the body side member facing away from the user from direct contactwith material exiting the stoma and thus from soiling or attack fromsuch material.

1. An ostomy appliance comprising a body side member (3) comprising anadhesive wafer for securing the appliance to the user's skin, said waferhaving a hole (7) for receiving a stoma (5), wherein the body sidemember comprises first substantially annular coupling means (2) forreleasable attachment of a separately exchangeable receiving bag to thebody side ostomy member for receiving secretions from the stoma, saidreceiving bag comprising matching second substantially annular couplingmeans, wherein the body side member comprises a separate sealing memberfor sealing against the stoma, wherein the separate sealing member is inthe form of a disc (1) having a centre hole (4) for accommodating thestoma (5) and wherein at least the surface of the disc facing the skinof the user comprises a mass of a skin-friendly adhesive, wherein thedisc has a maximum outer diameter corresponding to the inner diameter ofthe first annular coupling means and wherein the centre hole (4) of thedisc (1) has a diameter smaller than the diameter of the stoma-receivinghole (7) of the body side member ensuring that the disc (1) covers allof the surface of the adhesive wafer facing away from the user locatedbetween the first annular coupling means and the stoma, characterised inthat the disc is made from a material that may be detached, rinsed withwater without detergents and reapplied.
 2. An ostomy appliance asclaimed in claim 1 wherein the diameter of the centre hole (4) of thesealing member corresponds to the diameter of the stoma (5).
 3. Anostomy appliance as claimed in claim 1 wherein the annular couplingmeans (2) is in the form of matching flanges and adhesive surfaces. 4.An ostomy appliance as claimed in claim 1 wherein the annular couplingmeans (2) is in the form of matching coupling rings.
 5. An ostomyappliance as claimed in claim 4 wherein the thickness of the sealingmember (1) is of the same size as the distance between the surface ofthe adhesive wafer facing away from the user and the top of the couplingring (2).
 6. An ostomy appliance as claimed in claim 1 wherein thesealing member (1) is made from an adhesive being resistant to attackform visceral contents.
 7. An ostomy appliance as claimed in claim 6wherein the sealing member (1) is made from a skin-friendly adhesivebeing suitable for repeated adhering to and removal from the skin.
 8. Anostomy appliance as claimed in claim 7 wherein the skin-friendlyadhesive is made from a permanently tacky silicone adhesive.
 9. Anostomy appliance as claimed in claim 6 wherein the surface of the disc(1) facing away from the user is-covered with a non-tacky layer.
 10. Anostomy appliance as claimed in claim 9 wherein the surface facing awayfrom the user is covered with a non-tacky polymer film.
 11. An ostomyappliance as claimed in claim 9 wherein the non-tacky layer is asilicone rubber.
 12. A separately exchangeable sealing member (1) incombination with an ostomy body side member (3) comprising an adhesivewafer for securing the appliance to the user's skin, said wafer having ahole (7) for receiving a stoma (5), wherein the body side member (1)comprises substantially annular coupling means (2) for releasableattachment of a separately exchangeable receiving bag to the body sideostomy member for receiving secretions from the stoma, wherein thesealing member is in the form of a disc (1) having a centre hole (4) foraccommodating the stoma (5) and wherein at least the surface of the discfacing the skin of the user comprises a mass of a skin-friendlyadhesive, wherein the disc has a maximum outer diameter corresponding tothe inner diameter of the first annular coupling means (2) and whereinthe centre hole (4) of the disc (1) has a diameter smaller than thediameter of the stoma-receiving hole (7) of the body side member (3)with which the sealing member is intended to be used, characterised inthat the disc is made from a material that may be detached, rinsed withwater without detergents and reapplied.